Regulatory Compliance Associate jobs
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ASSOCIATE DIRECTOR REGULATORY LABELING
Support with developing draft labeling text (e.g. USPI, PPI, Med Guide, EU SmPC, EUPIL) to support marketing applications and labeling update of approved package inserts to support product lifecycle management. Support implementat...
| Company | Acadia Pharmaceuticals Inc. |
|---|---|
| Address | San Diego, CA |
| Category | Information Technology |
| Job type | Full-Time |
| Date Posted | a month ago See detail |
Associate Director Regulatory Labeling
Acadia Pharmaceuticals Inc.
San Diego, CA
Support with developing draft labeling text (e.g. USPI, PPI, Med Guide, EU SmPC, EUPIL) to support marketing applications and labeling update of approved package inserts to support product lifecycle management. Support implementat...
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Associate Director, Regulatory Affairs - Inflammation & Immunology
Biospace
New York, NY
Provide interpretation of regulatory authorities feedback, policies and guidelines.. Lead the development of regulatory strategic plans either directly in conjunction with project teams or through your reports. Own the preparation...
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Associate Director, Regulatory Affairs - Inflammation & Immunology
Biospace
New York, NY
Provide interpretation of regulatory authorities feedback, policies and guidelines.. Lead the development of regulatory strategic plans either directly in conjunction with project teams or through your reports. Own the preparation...
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Associate Director, Regulatory Affairs - Inflammation & Immunology
Biospace
Basking Ridge, NJ
Provide interpretation of regulatory authorities feedback, policies and guidelines.. Lead the development of regulatory strategic plans either directly in conjunction with project teams or through your reports. Own the preparation...
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Associate Director, Regulatory Affairs Advertising and Promotion
Biospace
California, United States
Provides commercial regulatory support to high-volume brands or therapeutic area and projects without managerial oversight, as appropriate. Reviews and approves promotional materials.. Serves as PRC Chair for one or more high-volu...
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Associate Director, IT Compliance
Biospace
Emeryville, CA
Ensures 4DMT IT operates in compliance to GxP, SOX & Privacy regulations & ensures compliance objectives are demonstrably met with auditable evidence on an ongoing basis. Builds effective partnerships with business process owners,...
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Associate Director, Regulatory Affairs Strategy - Genetic Medicine
Biospace
New York, NY
Provide interpretation of regulatory authorities feedback, policies and guidelines.. Lead the development of regulatory strategic plans either directly in conjunction with project teams or through your reports. Own the preparation...
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Senior Associate, Compliance Monitoring
Biospace
Basking Ridge, NJ
Responsible for activities related to developing, conducting, and reporting the Compliance Monitoring Plan (e.g., utilizing monitoring tools/reports, field monitoring and analytics). Annually evaluate and revise the CM plan as nec...
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Associate Director, US Medical Advertising and Promotions Regulatory (GI)
Biospace
Lexington, MA
Mentor and develop staff. Supervise, trains and provides technical and regulatory guidance to staff. You will serve as the chair of promotional review meetings, and assist commercial with the planning and prioritization of propose...
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Senior Research Associate- Compliance Review Phase
Inter-American Development Bank
Washington, United States
External Opening Date: May 9, 2024. External Closing Date: May 23, 2024. Job Field: Oversight, Audit & Compliance....
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Senior Research Associate- Compliance Review Phase
Inter-American Development Bank
United States
Senior Research Associate- Compliance Review Phase The IDB Group is a community of diverse, versatile, and enthusiastic people who come together on a journey to improve lives in Latin America and the Caribbean. The Compliance Revi...
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Associate Director - Regulatory Affairs - AD Promo
Biospace
Princeton, NJ
Provide strategic guidance for responsible products and disease states based on current regulatory environment and competitive landscape. Assess risk and advise on mitigation strategies to meet overall business need, while maintai...
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Associate Director, Global Regulatory Project Management and Strategic Planning - Neuroscience
Biospace
Remote
As Associate Director, Global Regulatory Project Management and Strategic Planning, you will partner with the program Global Regulatory Lead (GRL), co-lead and facilitate product-specific Global Regulatory Team (GRT) meetings and...
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Regulatory Operations Associate
Northern Trust
Chicago, IL
Unspecified
Coordinate logistics for engagements conducted by Northern Trusts regulators, including centralized meeting management. Work closely with relevant subject matter experts and stakeholders to organize and submit responses to regula...
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Associate Principal Scientist, Analytical External Capabilities & Compliance (EC&C).
Merck & Co., Inc.
Rahway, NJ
Execution of AR&D's externalization strategy and optimization of the operating model to deliver results aligned with enterprise goals. Partner with cross functional DCT's and Process Research & Development External Capabilities to...
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Global Compliance Ops Associate - Latin America
Passport
Remote - Oregon, United States
HTS Classification (Product catalogs, Shopify, Internal requests). Customs data integrity projects (Review of descriptions, HS codes, COO). Product Reviews (Ingredient lists, Country Prohibitions/Restrictions). Brand reviews to e...
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Senior Manager/Associate Director of Regulatory Affairs
Tempus
Chicago, IL
Developing and leading global regulatory strategies to support business objectives. Leading submissions and correspondence with global regulatory authorities, including 510(k),PMA, De Novo authorizations, IDE, MDR CE marking, UKCA...
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Associate Director Regulatory Process Development
Johnson & Johnson
Wycombe, PA
Support the global Regulatory Process strategy that aligns with overall business objectives. Support the generation and implementation of an E2E process management model across Global Regulatory Affairs (GRA), including connectiv...
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Senior Associate, Regulatory Oversight Management
Bny Mellon
Pittsburgh, PA
Communicates with internal and external parties as needed and makes recommendations on necessary procedural/control changes on Regulatory Oversight Management matters. Gathers data and prepares materials for more senior team membe...
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Associate Information Security Compliance Analyst - US
Intelsat
Virginia, United States
Support the 3rd party vendor assessment and IT Risk assessment programs. Provide support in analyzing cyber security and privacy policy programs supporting industry and government Security Compliance, and management as needed. Con...
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Associate Athletic Director for Compliance
Drexel University
Philadelphia, PA
Monitor coaching limits and duties. Provide rule interpretations to coaches and staff. Provide robust rules education sessions to coaches and staff. Develop continuing rules and compliance education programs for the University com...
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Associate Director, Quality Assurance (Quality Compliance)
Granules Pharmaceuticals
Chantilly, VA
Provide leadership and direction regarding cGMP Compliance at the Chantilly site to ensure adherence to applicable Regulations. Excellent knowledge of the 21CFR, ICH, and USP to interpret and apply Regulations with respect to any...
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Internal Audit- Compliance & Legal Audit-Dallas-Associate
Goldman Sachs
Dallas, TX
Develop and maintain an in-depth understanding of business areas, its products, and supporting functions. Identify risks, assess mitigating controls, and make recommendations on improving the control environment. Follow-up on open...
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Energy Associate (Regulatory)
An International Law Firm
Washington, DC
Description: Candidates must have strong interpersonal and communication skills, a track record of insightful research and analysis, and persuasive writing abilities. We are looking for candidates who can and want to assume immedi...
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Compliance and Regulatory Lead
Kohler
New York, NY
Secure US and select international regulatory authorization for health/wellness products Oversee maintenance of regulatory licenses, registrations and listings Work with commercial team to ensure advertising and promotions comply...
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Associate Director, Global Regulatory Labeling
Biospace
Cambridge, MA
Develop and maintain current knowledge of labeling regulations and industry standards for labeling and communicate requirements to stakeholders as needed.. Direct the labeling control process for tracking, implementation, and regu...
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Associate Attorney - Regulatory Law
Clark-Esposito Law Firm, P.c.
Norwalk, CT
Are you a person who embodies the principle that "excellence is a habit and not an act?". Do you want to help companies navigate the complexities of acquiring government approvals? Does the thought of working on issues involving l...
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Regulatory Affairs Associate - Drug Products (Princeton, NJ (USA), US)
Laboratoire Guerbet
Princeton, NJ
Participate in pre-submission meetings with FDA in order to agree on potential regulatory pathways, clarification and follow-up of submissions under review. Coordinate preparation, review, submission of e-CTD regulatory dossiers t...
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Director, Regulatory Affairs - Advertising, Promotion and Regulatory Compliance
Ferring Pharmaceuticals
Parsippany, NJ
Manage Regulatory Affairs, Advertising & Promotion and Compliance GroupManage the US RA Ad Promo, submission operations, labeling and compliance group staff, including objective setting and career development activities and motiva...
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Senior Associate of Regulatory Affairs, CMC
Meitheal Pharmaceuticals Inc
Chicago, IL
Other duties may be assigned. Serves as the primary regulatory interface with global US FDA manufacturing partners , and internal teams to ensure the business needs for the assigned products are met by anticipating, identifying,...
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